Prescription drug
Where is Temsirolimus made?
5 companies sell it under their own name. Their labels name 3 factories in India and Ireland.
India 2Ireland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.25 mg per 1 mL · NDC 16729-223 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Fresenius Kabi USA, LLC25 mg per 1 mL · NDC 65219-200 | Gland Pharma LimitedMakes it and tests it | Visakhapatnam, India | No problems foundJul 2023 |
| Gland Pharma Limited25 mg per 1 mL · NDC 68083-202 | Gland Pharma LimitedMakes it and tests it | Visakhapatnam, India | No problems foundJul 2023 |
| Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. Torisel25 mg per 1 mL · NDC 0008-1179 | Pfizer Ireland Pharmaceuticals Unlimited CompanyMakes the active ingredient and tests it | Ringaskiddy, Ireland | Problems found, fixed voluntarilyOct 2024 |
| Almaject, Inc.25 mg per 1 mL · NDC 72611-785 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Oct 10, 2014 · Class III · Pfizer Inc.
Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue. - Nov 26, 2012 · Class III · Pfizer Inc.
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.